12 results
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28ms
·
Sources: EU EUDAMED, US FDA
SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Beyes
FDA UDI
Beyes Dental Canada Inc·00990010300859·FG CARBIDE 701L
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677606·Proximity 3-Level ACP, 61 mm
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677637·Proximity 3-Level ACP, 61 mm
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677613·Proximity 3-Level X-Lordotic ACP, 61 mm
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677620·Proximity 3-Level X-Lordotic ACP, 61 mm
ViSi Mobile Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRIMELENE 4/0 (1.5) 90 CM 2XHR26 CV
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAW·March 18, 2014
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 29, 2012
PEG DRILL SIZE 1 - 2
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code HTW·September 20, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015